Respiratory Training in Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain; Ultrasonography
• Interventions: Other: Isolated inspiratory training; Other: Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training

• Registration Number: NCT04582812
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

Objective: To determine the effectiveness of bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in patients with low back pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 96 patients with low back pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with bilateral and simultaneous diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-03
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-12
• Study Start: 2022-11-30
• Primary Completion: 2024-01-15
• Status Verified: 2024-02
• Study Completion: 2024-02-19
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Patients with low back pain during 6 weeks

Exclusion Criteria

• Neural disorders
• Systemic disorders
• Cognitive disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isolated high-intensity inspiratory muscle training	Isolated inspiratory training	-
Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training	Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training	-

Primary Outcome Measures

Name	Time	Method
Diaphragm muscle thickness	Change from Baseline diaphragm muscle thickness at 8 weeks	Diaphragm muscle thickness in centimeters evaluated by ultrasonography

Secondary Outcome Measures

Name	Time	Method
Pressure pain threshold	Change from Baseline pressure pain threshold at 8 weeks	Pressure pain threshold in kilograms / squared centimeter evaluated by algometer
Health-related quality of life scores	Change from Baseline health-related quality of life scores at 8 weeks	Quality of life scores evaluated by the self-reported Medical Outcomes Study Short-Form 36 questionnaire from 0 (lowest health-related quality of life) to 100 (highest health-related quality of life)
Pain intensity: Visual Analogue Scale	Change from Baseline pain intensity at 8 weeks	Pain intensity scores evaluated by the Visual Analogue Scale from 0 (No pain) to 100 millimeters (Worst pain)
Disability	Change from Baseline disability at 8 weeks	Disability scores evaluated by the self-reported Roland-Morris Disability Questionnaire from 0 (no disability) to 24 points (Maximum disability)
Respiratory parameters percentage	Change from Baseline respiratory parameters percentage at 8 weeks	Respiratory parameters percentage evaluated by spirometry

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain